Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

Device

COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

Applicant

Roche Molecular Systems, Inc.

4300 hacienda drive

pleasanton, CA 94588-2722

PMA Number

P050028

Supplement Number

S013

Date Received

02/08/2011

Decision Date

02/24/2011

Advisory Committee

Microbiology

Supplement Type

30-day notice

Supplement Reason

process change - manufacturer/sterilizer/packager/supplier

Expedited Review Granted?

No

Combination Product

No

Approval Order StatementElimination of the in-process chemical testing of the buffer concentrate component of the master mix used with the cobas ampliprep/cobas taqman hbv test, v2. 0 within the fda approved pcr manufacturing center (pmc) facility in branchburg, new jersey.